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STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY (Tum001)

18. mars 2022 oppdatert av: Società Italiana Talassemie ed Emoglobinopatie

STUDY MULTICENRIC OBSERVATIONAL, NO-PROFIT FOR THE INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY

The Trial aims to increase the information available on the relevance of tumor pathology in hemoglobinopathies, updating the data relating to hepatocarcinoma and investigating which other tumors are more frequent in patients with hemoglobinopathies. Still, in relation to tumor pathology, the study will evaluate any differences between the different types of hemoglobinopathy and will investigate the association between the appearance of neoplasms and risk factors such as age, sex, iron accumulation markers, history of bone marrow transplant, and others.

Studieoversikt

Status

Rekruttering

Forhold

Malignacy, Hemoglobinopathie

Detaljert beskrivelse

By providing targeted screening strategies, these data may contribute to the early identification of tumor pathology in hemoglobinopathies, and, by contributing to the identification of risk factors, to its prevention. They will also be able to contribute to understanding which therapeutic approaches in the case of cancer are most appropriate in this category of subjects.

To be able to go even deeper into understanding the possible link that exists between tumors and hemoglobinopathy, a further data collection (substudy) has been prepared in which additional and more detailed information will be collected in order to evaluate which is the percentage of patients who develop tumors compared to all those with hemoglobinopathy.

The risk of developing tumors will also be assessed for each hemoglobinopathy (transfusion-dependent beta-thalassemia, transfusion independent beta-thalassemia, hemoglobin H disease, sickle cell disease, microdrepanocytosis)

Studietype

Observasjonsmessig

Registrering (Forventet)

10000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: RAFFAELLA ORIGA, MD
Telefonnummer: 528 39 070 6095655
E-post: SECONDACASELLA@HOTMAIL.IT

Studiesteder

Italia
- - Cagliari, Italia, 09121
    - Rekruttering
    - Azienda Ospedaliera Universitaria di Cagliari
    - Ta kontakt med:
      
      RAFFAELLA ORIGA, MD
      
      Telefonnummer: -518 +39 070 6095655
      
      E-post: SECONDACASELLA@HOTMAIL.IT

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Living or deceased adult or pediatric (male and female) patients with transfusion-dependent (TDT) or independent (NTDT) beta-thalassemia, hemoglobin H disease, sickle cell anemia and microdrepanocytosis who have developed tumor disease during life.

Beskrivelse

Inclusion Criteria:

Transfusion-dependent or independent beta-thalassemia, hemoglobin H disease, sickle cell anemia and microdrepanocytosis
Current or previous malignant tumor pathology
Availability of medical history including the most relevant clinical and instrumental data before the onset of cancer

Exclusion Criteria:

- Other haematological diseases other than hemoglobinopathies
Absence of neoplastic events in the clinical history
Non-availability of relevant clinical and instrumental data

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
outcome 1 Tidsramme: ENROLLMENT STUDY	Evaluate the number of patients with hemoglobinopathy followed at Italian centers that have developed neoplastic events in the last decades	ENROLLMENT STUDY
outcome 2 Tidsramme: enrollment study	Evaluate which neoplasms are most associated with hemoglobinopathies	enrollment study
outcome 3 Tidsramme: enrollment study	Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.	enrollment study

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
outcome 4 Tidsramme: enrollment study	To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events	enrollment study
outcome 5 Tidsramme: enrollment study	Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies	enrollment study
outcome 6 Tidsramme: enrollment study	Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies	enrollment study
outcome 7 Tidsramme: enrollment study	Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes	enrollment study
outcome 8 Tidsramme: enrollment study	To evaluate the incidence rate of neoplasms in the total population of patients affected by hemoglobinopathies and in the various forms of hemoglobinopathy.	enrollment study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Società Italiana Talassemie ed Emoglobinopatie

Etterforskere

Hovedetterforsker: RAFFAELLA ORIGA, MD, Azienda Ospedaliero Universitaria di Cagliari

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2022

Primær fullføring (Forventet)

28. februar 2024

Studiet fullført (Forventet)

28. februar 2052

Datoer for studieregistrering

Først innsendt

9. mars 2022

Først innsendt som oppfylte QC-kriteriene